Instructions

• Please use this PowerPoint as a template for presentation of your study protocol for the IRB
• Make necessary changes or update in slides to suit your study protocol.
• Once you are ready for process of update, delete this first slide & finalise the entire protocol.
• “ALL THE BEST”

IRB, Narendra Modi Medical College

1

Research Study Title here

Name of Investigators with Designation and Department

IRB, Narendra Modi Medical College

2

Background / Introduction

• Most of the time faculty members can easily understand the rationale for the study. So, this may be omitted completely.
• However, if you still wish to have this, keep it very short (just 1 slide here)

IRB, Narendra Modi Medical College

3

Hypothesis or a Research Question

• If you have any hypothesis or a “SMART” Research Question, write it on this slide.

IRB, Narendra Modi Medical College

4

Aim & Objectives

• Details here…

IRB, Narendra Modi Medical College

5

Methodology

• Type of study or Study design
• Study subjects
• Selection criteria (Inclusion & Exclusion)
• Sampling technique, sample size & details of sample size calculation
• Ethical considerations

(All these may be spread apart in

few slides as per the content)

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IRB, Narendra Modi Medical College

6

Methodology

• Details / steps of the proposed methodology. How patients are enrolled. What is routinely done. What will be followed after enrolment.
• Please ensure that study remain within the purview of observational study

IRB, Narendra Modi Medical College

7

Study tool

• Details of the study tool / format / questionnaire / Case Record Form

IRB, Narendra Modi Medical College

8

Informed consent form

• Whenever applicable
• It need to be in minimum two languages
• It should ideally include all information regarding the participation, risk of participation if any, consent for use of photograph etc and not just a plain consent for participation

IRB, Narendra Modi Medical College

9